BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Confirm Biosciences LLC

    Reg #: 3006048451 · FEI: 3006048451 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    30

    Registration Details

    Registration Name
    Confirm Biosciences LLC
    Registration Number
    3006048451
    FEI Number
    3006048451
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    8866 Cypress Court, Building E
    City
    SAN DIEGO
    State
    CA
    ZIP
    92154
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN240029

    Owner / Operator

    Firm Name
    Confirm Biosciences LLC
    Operator Number
    9095540
    Address
    8866 Cypress Court, Building E
    City
    San Diego
    State
    CA
    Postal Code
    92154
    Country
    US
    Correspondent
    Ryan Stashak

    Products

    Device Name Product Code
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Amphetamine DKZ
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Opiates DJG
    Test, Propoxyphene, Employment And Insurance Testing, Exempt PVI
    Container, Specimen, Urine, Drugs Of Abuse, Over The Counter MPQ
    Test, Propoxyphene, Over The Counter QBF
    Test, Opiates, Over The Counter NGL
    Test, Cannabinoid, Over The Counter NFW
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Methamphetamine, Over The Counter NGG
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Methadone, Over The Counter PTG
    Test, Barbiturate, Over The Counter PTH
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Amphetamine, Over The Counter NFT
    Test, Benzodiazepine, Over The Counter NFV
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Test, Opiates, Employment And Insurance Testing, Exempt PVH
    Test, Cannabinoid, Employment And Insurance Testing, Exempt PVJ
    Test, Morphine, Employment And Insurance Testing, Exempt PVG
    Enzyme Immunoassay, Propoxyphene JXN
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Test, Methaqualone, Employment And Insurance Testing, Exempt PVF

    Proprietary Names

    HealthConfirm Covid Flu A/B (OTC) DrugConfirm Urine Drug Test Kits Test, propoxyphene, employment and insurance testing, exempt Drugconfirm Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card PREGNANCY ONE STEP RAPID TEST Test, opiates, employment and insurance testing, exempt Test, cannabinoid, employment and insurance testing, exempt Test, morphine, employment and insurance testing, exempt Accurate Multi Panel Drug Urine Test Cup Test, methaqualone, employment and insurance testing, exempt

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device